Caveat Emptor for Heart Failure Patients Considering Stem Cell Tx – MedPage Today

By Sykes24Tracey

Cardiac stem cell treatments are being sold to patients with heart failure without effective regulatory monitoring, researchers found.

Paul J. Hauptman, MD, of St. Louis University Hospital, and colleagues identified 61 centers offering such therapies, with 30 responding to the team's telephone survey. While most claimed to use autologous stem cells alone (83.3%), none of the sites disclosed how they isolated or identified these cells.

Hauptman's group, reporting in JAMA Internal Medicine, found 79 physician profiles from 39 stem cell center websites. Online registries confirmed that only one was board-certified in cardiology, 55 were board-certified in another field; and 13 had unverified certifications. Of note were the ten that admittedly had zero formal medical training, calling themselves "naturopathic medical doctors."

Only nine out of the 30 responding centers said they required medical records from their patients, six of them a cardiologist's note.

"We found that [stem cell] treatment is delivered without rigorous preprocedural evaluations or postprocedural followup. Most physicians were not board certified in cardiology," according to the investigators. "The reasons why these businesses can continue to operate are not clear; in a recent publication, the former FDA commissioner did not address the FDA's role, though some monitoring of these businesses does occur."

"Given the prognosis of advanced heart failure and relatively limited options, clinicians need to be aware that patients may seek out this option and thereby may expose themselves to uncertain medical risks at considerable financial and transactional cost. The implications for regulatory policy are significant."

Of 61 stem cell centers identified in 2016, 15 were satellite sites; seven centers had inactive websites or had been shut down by the FDA; two couldn't be contacted; two refused to participate; three said they didn't offer heart failure treatment despite claims online; one didn't treat severe heart failure; and one demanded $250 for telephone consultation with the researchers.

The average price for a single treatment was $7,694 for autologous cells, while allogeneic cells went for $6,038. Multiple procedures were eligible for some discount (average $3,893) at seven centers; in addition, two offered a $500 discount for cash payments.

Hauptman reported consulting for St Jude Medical, Sensible-Medical, Corvia, Array Biopharma, and Relypsa; serving on the speaker bureau for Relypsa and Otsuka; and getting research funding from Alnylam, Relypsa, and the National Heart, Lung and Blood Institute.


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